Baxter Dialysis Machines (2020-11-17)
- Starting date:
- November 17, 2020
- Posting date:
- December 11, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74515
Last updated: 2020-12-10
Affected Products
A. Artis
B. Phoenix
C. Artis Physio
Reason
Baxter has not validated the use of any connectors placed between the blood set and the patient's blood access with Baxter dialysis machines. The use of connectors with potentially incompatible material may increase the risk for leakage in the extracorporeal circuit and may prevent a secure connection between the blood set and the patient's blood access device.
Affected products
A. Artis
Lot or serial number
All lots.
Model or catalog number
112949
Companies
- Manufacturer
-
Gambro Dasco S.P.A.
Via Modenese 66
Medolla
41036
ITALY
B. Phoenix
Lot or serial number
All lots.
Model or catalog number
6022966700
6023006700
Companies
- Manufacturer
-
Gambro Dasco S.P.A.
Via Modenese 66
Medolla
41036
ITALY
C. Artis Physio
Lot or serial number
All lots.
Model or catalog number
115965
Companies
- Manufacturer
-
Gambro Dasco S.P.A.
Via Modenese 66
Medolla
41036
ITALY